Data from clinical assays (biomarkers, PK, PD, and immunogenicity) are often key outcomes from clinical trials. Implementing these endpoints in clinical trials is very costly and also time - and resource-consuming. Therefore, ensuring that appropriate measures are taken from the collection of samples until the completion of laboratory testing is paramount.
The purpose of this presentation is to discuss the challenges and potential pitfalls of sample collection, processing, and storage on the final bioanalytical endpoints and laboratory assays. Key parameters affecting various assay endpoints will be discussed and illustrated with specific examples, highlighting the SGS approach to handling and controlling these critical activities for the successful delivery of these studies outcomes.
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